Analysis of Three-dimensional Movements of the Head in Cervical Dystonia (STAC1)

October 21, 2016 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Analysis of 3-D Movements of the Head in Cervical Dystonia: Comparative Assessment of the Cervical Mobility With the Mean of 3D Sensors Motion Capture Between Patients With Cervical Dystonia and Control Subjects

This study addresses postures and range of motion in cervical dystonia (Spasmodic Torticollis). It uses 3D miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. In addition, the clinical state of cervical dystonia of the patients will be assessed, using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). The investigators will compare the results between control and study groups.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study-group: 30 patients meeting the criteria for cervical dystonia (Spasmodic Torticollis) and without botulinum toxin injections during the last 6 previous months before baseline. Patients will be selected consecutively among the outpatients with movement disorder of 3 study sites: Fondation OPH Rothschild, Salpetriere Hospital and Sainte-Anne Hospital (Paris)

Control-group: 30 healthy volunteers matched in age (+/- 5 years) and gender with the 30 CD subjects. They will be selected in Sainte-Anne Hospital (Paris)

Description

Inclusion Criteria:

  • Segmental cervical dystonia diagnosed by a neurological specialist in movement disorders

Exclusion Criteria:

  • Neurological pathology other than cervical dystonia such as Parkinson's disease, head tremor, severe pain or cervical ailment, which would have required a treatment within the last six months
  • Neuroleptic treatment in course
  • Pregnancy
  • breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cervical dystonia
matched controlled subjects
matched in age (+/- 5 years) and gender

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion of the voluntary mobility of the cervical spine in the three spatial planes
Time Frame: baseline
Range of motion of the voluntary mobility of the cervical spine in the three spatial planes, measured in patients and matched control subjects
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
movements disorders in cervical dystonia
Time Frame: baseline
correlations between the movements disorders (range of motion, angular velocity, direction deviation) and the clinical characteristics of cervical dystonia, among patients with cervical dystonia
baseline
head posture
Time Frame: baseline
influence of vision on the head posture
baseline
range of motion
Time Frame: baseline
influence of vision on the range of motion
baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
score on the Toronto Western Spasmodic torticolis rating scale
Time Frame: baseline
clinical characteristics of cervical dystonia
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Sangla Sophie, MD, Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (ESTIMATE)

February 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01400-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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